Insulin Resistance, Body Weight
Conditions
Brief summary
The goal of this randomized controlled trial is to test the effect of time-restricted eating (14-hour fast, 10-hour eating window) of a low-energy dense diet (reduced calories per gram of food) in older adults with obesity and insulin resistance. The study aims to determine if modulating the energy density of the diet reduces: 1. Insulin resistance and 2. Body weight. Researchers will compare the groups: 1. Following time-restricted eating and given a diet reduced in energy density or 2. Following time-restricted eating and given a diet typically consumed in this population
Detailed description
The study is an eight-week randomized controlled double-blinded clinical trial. Participants will follow time-restricted eating (14-hour fast, 10-hour eating window), and will be randomized to a diet low in energy density or the usual diet. Meals will be prepared in a metabolic kitchen and dispensed to participants. Dietitians will monitor dietary compliance. A blood sample will be drawn and body weight will be measured before starting the intervention and after completing it.
Interventions
BEHAVIORALLow-energy dense diet
Subjects will follow time-restricted eating of a low energy dense diet
BEHAVIORALUsual diet
Subjects will follow time-restricted eating of the usual diet
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Subjects will be randomly assigned to one of two groups. Except for the Director of the Metabolic Kitchen and the dietitians assigned to the study, all other researchers conducting the study will be blinded to the treatment group assignment of subjects.
Intervention model description
Subjects will be randomly assigned to receive a diet low in energy density or the usual diet.
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Body mass index (BMI) ≥ 30kg/m2. 2. Mini-Mental State Examination (MMSE) \> 25 3. Geriatric Depression Scale-15 (GDS-15) \< 9 4. Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3.
Exclusion criteria
1. Diagnosis of Type 2 diabetes received more than five years ago 2. Diagnosis of type 1 diabetes 3. Evidence of clinically significant renal dysfunction or disease 4. History of malignancy during the past five years 5. Being treated with systemic steroids, olanzapine, or clozapine 6. Being treated with prescription medications for obesity 7. Being treated with thiazolidinediones, glucagon-like-receptor agonists, Dipeptidyl Peptidase IV inhibitors, and insulin 8. Weight change \> 3 kg in the preceding three months 9. Any disease or condition that precludes testing of the study outcomes or makes it unsafe to consume the foods being tested in the study, or subjects are otherwise deemed to be unsuitable for participation in the study (determined by the investigative team)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain Insulin Resistance | 8 weeks | Phosphorylation of serine 312 on insulin receptor substrate 1 in plasma neural-derived exosomes |
| Ketones | 8 weeks | Ketones |
| Body weight | 8 weeks | Body weight |
| Peripheral insulin resistance | 8 weeks | Homeostasis model assessment of insulin resistance (HOMA-IR) |
Countries
United States
Outcome results
None listed